The Fibrin Pad CV Phase III Study

Phase 3

Completed

Conditions: Cardiovascular Disease

Interventions: Biological: EVARREST™ Fibrin Sealant Patch
Biological: Topical hemostat

Registration Number: NCT02040428

Lead Sponsor: Ethicon, Inc.

Brief Summary: The objective of this study is to evaluate the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 156

Inclusion Criteria

Subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass. Subjects in Japan between ≥18 and <20 years of age will require consent by the subject's legal representative
Subjects must be willing to participate in the study and provide written informed consent.
Presence of an appropriate Target Bleeding Site (TBS) along the anastomotic suture line, involving a synthetic aortic graft, as identified intra-operatively by the investigator;

Exclusion Criteria

Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 60 day follow up period after surgery.
Female subjects who are pregnant or nursing.
TBS is from a large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of EVARREST™ Fibrin Sealant Patch to blood flow and/or pressure during absorption of the product;
TBS with major arterial bleeding requiring suture or mechanical ligation;
TBS involves an expanded polytetrafluoroethylene (ePTFE) graft
TBS within an actively infected field;
Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
Subjects with any intra-operative findings identified by the investigator that may preclude conduct of the study procedure;

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EVARREST™ Fibrin Sealant Patch	EVARREST™ Fibrin Sealant Patch	EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
Topical hemostat	Topical hemostat	Equine collagen with Human Fibrinogen and Human Thrombin

Primary Outcome Measures

Name	Time	Method
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.	Intraoperative, 3 minutes following treatment application	Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application	Intraoperative, 6 minutes following treatment application	The number of subjects achieving hemostatic success at 6 minutes following treatment application with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application	Intraoperative, 10 minutes following treatment application	The number of subjects achieving hemostatic success at 10 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.
Number of Participants With Re-bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment	Intra-operative, prior initiation of final chest wall closure.	The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had intra-operative re-bleeding requiring treatment at the TBS

Trial Locations

Locations (24): Clinical Investigation Site #14
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Indianapolis, Indiana, United States
Clinical Investigation Site #16
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Baltimore, Maryland, United States
Clinical Investigation Site #73
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Sydney, New South Wales, Australia
Clinical Investigation Site #15
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Atlanta, Georgia, United States
Clinical Investigation Site #21
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Bethesda, Maryland, United States
Clinical Investigation Site #17
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Saint Louis, Missouri, United States
Clinical Investigation Site #10
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Paterson, New Jersey, United States
Clinical Investigation Site #12
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New York, New York, United States
Clinical Investigation Site #20
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Philadelphia, Pennsylvania, United States
Clinical Investigation Site #72
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Camperdown, New South Wales, Australia
Clinical Investigation Site #18
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Houston, Texas, United States
Clinical Investigation Site #71
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Brisbane, Queensland, Australia
Clinical Investigation Site #74
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Bedford Park, South Australia, Australia
Clinical Investigation Site #70
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Melbourne, Victoria, Australia
Clinical Investigation Site #40
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Gent, Belgium
Clinical Investigation Site #82
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Kanagawa, Isehara-shi, Japan
Clinical Investigation Site #81
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Saitama, Saitama-shi, Japan
Clinical Investigation Site #80
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Osaka, Suita-shi, Japan
Clinical Investigation Site #33
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Bristol, England, United Kingdom
Clinical Investigation Site #35
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Cottingham, England, United Kingdom
Clinical Investigation Site #34
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Manchester, England, United Kingdom
Clinical Investigation Site #32
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Aberdeen, Scotland, United Kingdom
Clinical Investigation Site #31
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Clydebank, Scotland, United Kingdom
Clinical Investigation Site #30
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Edinburgh, Scotland, United Kingdom